Subchronic feeding study of high oleic acid soybeans (Event DP-3Ø5423-1) in Sprague-Dawley rats.
DP-3Ø5423-1 (305423) is a genetically-modified (GM) soybean that was produced by biolistic insertion of a gm-fad2-1 gene fragment and the gm-hra gene into the germline of soybean seeds. The gm-fad2-1 gene fragment cosuppresses expression of the endogenous FAD2-1 gene encoding the seed-specific omega-6 fatty acid desaturase resulting in higher concentrations of oleic acid (18:1) relative to linoleic acid (18:2). The gm-hra gene encoding a modified acetolactate synthase (ALS) enzyme was used as a selectable marker. In the current study, processed fractions (meal, hulls, and oil) from 305423 soybeans, non-GM soybeans with a similar genetic background (near isoline control) and three commercially-available non-GM varieties were used to formulate diets that were nutritionally comparable to PMI Certified Rodent LabDiet 5002. Diets were fed to young adult Crl:CD(SD) rats (12/sex/group) for approximately 90 days. Compared with rats fed the non-GM control diet, no biologically relevant differences were observed in rats fed the 305423 diet with respect to body weight/gain, food consumption/efficiency, mortality, clinical signs of toxicity, or ophthalmological observations. No test diet-related effects were observed on neurobehavioral assessments, organ weights, or clinical or anatomic pathology. These results demonstrated that 305423 soybeans are as safe and wholesome as non-GM soybeans.
Delaney
Bryan
B
Pioneer, A DuPont Company, Pioneer Hi-Bred International Inc., Johnston, IA 50131-0552, USA. bryan.delaney@pioneer.com
Appenzeller
Laura M
LM
Munley
Susan M
SM
Hoban
Denise
D
Sykes
Greg P
GP
Malley
Linda A
LA
Sanders
Craig
C
D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D001777:Blood Coagulation / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D004032:Diet; D004435:Eating / Q000187:drug effects; D005123:Eye / Q000473:pathology; D005260:Female; D008297:Male; D019301:Oleic Acid / Q000032:analysis / Q000633:toxicity*; D030821:Plants, Genetically Modified; D051381:Rats; D017207:Rats, Sprague-Dawley; D013025:Glycine max / Q000737:chemistry* / Q000235:genetics / Q000633:toxicity*
D019301:Oleic Acid